Somerset-based Catalent on Thursday announced the signing of a commercial supply agreement with Harm Reduction Therapeutics, whereby Catalent will manufacture the Pittsburgh-based pharmaceutical company’s naloxone nasal spray, RiVive, for the emergency treatment of known or suspected opioid overdose.
Harm Reduction Therapeutics, a 501(c)(3) nonprofit pharmaceutical company that received Priority Review status in December from the U.S. Food and Drug Administration for its over-the-counter naloxone nasal spray New Drug Application.
Since 2017, Harm Reduction Therapeutics has been working on a low-cost, OTC naloxone product to act as a critical tool to help stem the loss of life from the U.S. opioid crisis. In anticipation of FDA approval in July 2023 and U.S. launch in early 2024, Catalent will manufacture RiVive at its facility in Morrisville, North Carolina.
“This agreement marks a major milestone for Harm Reduction Therapeutics and is also a significant step forward in tackling a major public health issue in this country,” Carla Vozone, vice president of inhalation strategy at Catalent, said. “Our company is driven by a ‘patient-first’ culture, which is synergistic with the goals and mission of our partner on this project, and we take great pride in being associated with such a potentially life-changing program.”
Catalent’s 180,000-square-foot inhalation development facility in Morrisville includes development and manufacturing for unit-dose, bi-dose and preserved multidose nasal sprays, as well as comprehensive spray testing capabilities. It works alongside Catalent’s facility in Durham, North Carolina, to support global customers with an extensive range of small molecule and biologic analytical services.
